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POC Test for Identifying Viraemic HCV Infection

J Hepatol; ePub 2019 Feb 21; Freiman, et al

A diagnostic test with a limit of detection (LOD) would identify 97% of viraemic hepatitis C virus (V) infections among nearly all populations, a recent study suggests. Researchers established a multi-country cross-sectional dataset of first available quantitative HCV RNA linked to demographic and clinical data and analyzed the distribution of HCV RNA to determine critical thresholds for detection of HCV viraemia. Logistic regression was performed to evaluate factors associated with low-level viraemia (LLV), and relative sensitivities for significant covariates were derived. Among the findings:

  • The dataset included 66,640 participants with HCV viraemia from Georgia (44.4%), Canada (40.9%), India (8.1%), Cambodia (2.6%), Egypt (1.6%), Pakistan (1.3%), Cameroon (0.4%), Indonesia (0.2%), Thailand (0.2%), Vietnam (0.1%), Malaysia (0.05%), and Mozambique (0.02%).
  • A test with an LOD of 1,318 IU/mL would identify 97% of viraemic HCV infections among almost all populations.
  • Only the younger age group had a decreased relative sensitivity below 95% at 93.3%.


Freiman JM, Wang J, Easterbrook PJ, et al. Deriving the optimal limit of detection for an HCV point-of-care test for viraemic infection: Analysis of a global dataset. [Published online ahead of print February 21, 2019]. J Hepatol. doi:10.1016/j.jhep.2019.02.011.